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RTF Template

National Authority Of Medicines And Medical Devices

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	432D
2. Name of Authorisation Holder	:	Pi Pharma M&D S.R.L. (ORG-100014380 / LOC-100020276)
3. Address(es) of Site(s)	:	Intrarea Filmului nr. 45, Bucureşti, Sector 6, cod 062394, Romania

4. Legally registered address of Authorisation Holder	:	Intrarea Filmului 45 Etaj 3, Bucharest, 632394
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-12-18
10. Annexes attached	:	Annex 1 Scope of wholesale distribution authorisation Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number Annex 3 (Optional) Name(s) of responsible person(s) Annex 4 (Optional) Date of Inspection on which authorisation was granted Annex 5 (Optional) Additional provisions based on national requirements

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: PI PHARMA M&D S.R.L.

, Intrarea Filmului nr. 45, Bucureşti, Sector 6, cod 062394, Romania

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The current WDA is valid only if the terms of the storage and logistical services agreement signed with Versus Pharma Logistics SRL and the terms of transportation services agreement signed with Frigospeed Eurotop SRL, Pharma Expertspedition SRL which are using an transportation hub in Dolj, Timișoara, Alba Iulia, Balux Lituania counties and Wellivery Business SRL which is using an transportation hub in Arges county.

Prezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile contractului de custodie încheiat cu Versus Pharma Logistics SRL. Transportul se efectuează şi în baza contractelor de prestări servicii transport încheiate cu: Frigospeed Eurotop SRL, Pharma Expertspedition SRL, care utilizează noduri de transport în jud. DJ, TM, AB, Balux Lituania și Wellivery Business SRL care utilizează un nod de transport în jud. AG.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Union Format for a Wholesale Distribution Authorisation	432D
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